A phase I study compared vaccines of lethally irradiated cultured autologous tumor cells from RCC patients
post-nephrectomy that were either transfected with the GM-CSF gene by the replication defective retroviral vector MFG or  left untransfected.

    Only minor toxicities were reported from the effects of primary culture alone or the addition of human GM-CSF gene transfer.
 
 

                               non-GM-CSF transfected vaccine                            GM-CSF transfected vaccine

                             post 3 days                    post 7 days                       post 3 days                    post 7 days

    Of interesting note was the presence of eosinophils as shown here by anti-MBP.  Eosinophils are involved in both allergic reactions and cytocidal responses to parasitic infections, and also have been shown to act a APCs after being stimulated with GM-CSF in vitro.
    In one patient, urticaria and pruritus (allergic reactions) at the DTH site followed the treatment with the GM-CSF transduced vaccine after partial regression of the patient's tumor was measured by CT scan (see below).
Simons et al.:Bioactivity of Autologous Irradiated Renal Cell Carcinoma Vaccines Generated by ex Vivo
Granulocyte-Macrophage Colony-stimulating Factor Gene Transfer.  Cancer Research, 57: 1537-1546, 1997.
 
 
 
 
 
 
 

The following are CT scans of one patient in the study who demonstrated reduction of multiple metastases (spontaneous regression can not be ruled out):

                At Surgery                         Pre-Treatment,                   28 days post 1st vaccination            after 3 treatments
                                                        2 mo. post surgery                                                                (6 months post vaccination)